With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.
- Standards For New Technologies: Easy Listening For Outsourcing
- No, Biologics Are Not Natural Monopolies
- Illuminating the Need for Standards in Regenerative Medicine and Advanced Therapy
- Are You Approaching LIMS Validation Correctly?
- Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs
- The Potential And Future Of Cell Therapy
- USP Targets Advanced Manufacturing For U.S.-Made Generics
No, Biologics Are Not Natural Monopolies
Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.
Illuminating the Need for Standards in Regenerative Medicine and Advanced Therapy
In the past, standards development in the life sciences has required years. This can be attributed to the passive process which has been primarily based on volunteer contributors from industry. The Standards Coordinating Body (SCB) accelerates the process by focusing on high priority/high impact standards and catalyzing the process.
Are You Approaching LIMS Validation Correctly?
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs
The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits.
The Potential And Future Of Cell Therapy
While the field has made laudable progress in developing novel biomolecules that can be used to control cell function (e.g. mRNA, DNA, CRISPR, siRNA, proteins, peptides, etc.), very little progress has been made on reliably delivering these materials to a cell and enabling robust engineering of cell function without significantly impairing cell health.
An Analysis Of The Gene Therapy Viral Vector Landscape
Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.
Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm
Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.
Making Sense Of Antibody Epitope Claims
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
PHARMA OUTSOURCING WHITE PAPERS
Enabling Biologic Drug Delivery Of Volumes Beyond 1 mL
As the biological drug design space evolves toward formulations with larger dose volume and higher viscosity, the device industry is adapting by developing more innovative delivery systems. To accommodate these advances, delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
End-To-End Thinking During Drug Product Development10/7/2020
In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.
Business Continuity Program: Maintain Operations During Crises5/5/2020
Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.
Three Options To Viral Vector Manufacturing Capacity9/1/2020
A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.
From Research To Commercial: A Seamless Supply Of Oligonucleotides4/24/2020
This white paper discusses how to meet the seamless supply challenge by providing development, scale-up and synthesis capabilities of research to commercial quantities of customized oligonucleotides.
Robust By Design: How BD Is Overcoming The Biologics Challenge In Drug Delivery9/18/2020
Autoinjectors used with pre-fillable syringes offer multiple benefits, from providing an accurate dosage to reducing the number of needlestick injuries (needles are protected after use). BD-designed autoinjectors can deliver drugs of differing viscosities in a well-integrated robust system.
COVID-19 AND YOUR SUPPLY CHAINS
The Latest Analysis And Advice From Outsourced Pharma
OUTSOURCED PHARMA CONTENT COLLECTIONS
Quality, Supply Chain Agility, Analytical Development: These are the subjects of three thought-provoking whitepapers on our biopharma industry, reviewed and analyzed for Outsourced Pharma readers by Chief Editor Louis Garguilo. Important in their own right, see how Garguilo pulls out the most salient points from the reports to help readers increase your understanding and efficacy of drug development and manufacturing outsourcing.More Content Collections